Quality and Safety in the Hospital: The Pharmacist is the Key Person

Hospitals are designed to cure patients – this sounds obvious. Hospitals should also be designed to assure the quality and safety of medical care. This is not an easy task as it is quite complex to master. In order to do so, each step of the drug circuit has to be controlled; this includes everything from the receipt of the drug to its administration to the patient. Nurses, medical staff, pharmacy technicians and pharmacists are committed to assuring the safety of medications. The pharmacist is involved in many steps of the drug circuit and is often the responsible person regarding quality and safety of the drug product. In this issue of PTHP we present a few examples of pharmaceutical studies aiming to improve or to assure the quality of drug products.

The first paper by Chennell et al., from Clermont-Ferrand in France, investigates visible particles caused by coring of medication vial stoppers. This study was performed on 40 vial stoppers in 16 situations and showed that the observed particle size was around 1 mm. Favoring factors were short beveled needles and 4 mm thick chlorobutyl vial stoppers. Using a 45° puncture angle reduced particle formation. This study is of importance because visible particles have been claimed responsible for a higher risk of pulmonary embolisms, phlebitis or granulomas. Unfortunately, very few similar studies are described in the literature. This field should thus be more investigated. A review on particulate matter has previously been published in our journal [1] and we will still encourage further communications in this field.

The second paper in this issue investigates radio frequency identification (RFID) tag detection rates using exploratory scenarios. It was proposed by Petit et al. from Ste Justine Hospital in Montreal, Canada. RFID is a way to perform traceability of goods (i. e. drug products in our case). In this paper the authors are evaluating 3 different 13.56 MHz RFID tags and a handheld RFID antenna in various situations. Optimal conditions have been defined by the authors. Once again, this type of study is scarce although really interesting for monitoring the quality of the drug circuit. In their conclusion the authors envision many developments of their application. We would be really interested to publish further developments of this application in this journal.

The third paper is published by the same hospital research team (Roland et al.) in another well known field of our journal: chemical contamination. Chemical contamination monitoring and control is of importance to assure the safety of patients by avoiding the presence of traces of non-desired drug products in formulations but also to assure the safety of workers. This is why it is a corner stone of quality control, especially in chemotherapy production units. This study is a review of 6-year chemical-contamination monitoring on three hazardous drugs (cyclophosphamide, methotrexate, ifosfamide). The aim is to follow contamination levels over time and the impact of the action taken to minimize surface contamination. Such a program should be implemented in every compounding pharmacy dealing with hazardous drugs. If possible contamination with platinum derivatives should also be monitored because the limits of quantification are very low if analytical techniques such as ICP-MS are being used. This allows detecting very low levels of chemical contamination as shown by a 15 year study recently published in our journal [2].

Another example of chemical contamination-monitoring is given in the paper from Drapeau et al. This study was performed in the hospital St Pierre de la Reunion in France overseas territories. The authors monitored the contamination by 5-FU in their chemotherapy units. The results are interesting as they can be used to benchmark this unit with others. Moreover, the authors have performed this first study in order to have a reference starting point with the aim to determine the impact of changes of their organization on the mean chemical contamination of the area over time. Thus they have the same idea in mind as the Canadians: to have a tool at their disposal that will enable them to manage the chemical quality of their environment.

Finally our last issue of PTHP ends with the study of Sorrieul et al. from Angers in France. This is another example of the role of the pharmacist in the field of safety and quality. In fact the authors have set up a High Pressure Liquid Chromatography (HPLC) method for the concomitant analysis of two drug compounds injected in the intrathecal space for spinal analgesia: ziconotide and sufentanil. This method makes it possible to control the concentration of both drugs in the solutions injected to refill the implantable pumps used to deliver the drugs to the patients. This quality control is important as these drugs have a narrow therapeutic index and thus overdosage may be very dangerous, especially after intrathecal infusion.

In conclusion this issue of PTHP provides 5 different examples of how the pharmacist is involved in the control of the quality in hospitals. We think that there will be many others published in our journal in the next years as pharmaceutical technology is one of the corner stone of safety and quality in pharmacy.